510(k) K201130 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ACUSON Juniper Diagnostic Ultrasound System
| Applicant | Siemens Medical Solutions USA, Inc., Moutain View CA, US |
| Decision | Substantially Equivalent, May 26, 2020 |
| Received | Apr 28, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201130
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 24, 2024 | Siemens Medical Solutions USA, Inc. ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software.
ACUSON Juniper Select 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11653093, with software. Open, Classified |
IYN | None listed |
| Apr 19, 2024 | Siemens Medical Solutions USA, Inc. ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF: 11653093, running software version VA10x with DICOM SR Cardiac option, from VB1 Open, Classified |
IYN | None listed |
| Jan 19, 2022 | Siemens Medical Solutions USA, Inc. Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE
Ultrasound imaging system intended for the following applications: Vascular, Abdominal, Neonatal, Echo Open, Classified |
IYN | None listed |
| Jul 12, 2021 | Siemens Medical Solutions USA, Inc. ACUSON Juniper Diagnostic Ultrasound System Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.